Kornimate/medical-research-clean huggingface dataset:
efficacy study of antimicrobial catheters to avoid urinary infections in spinal cord injured patients

Conditions: Urinary Tract Infection

Summary: the purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

antiseptic silver alloy-coated silicone urinary catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients. the study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. the study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. participants are on-line centrally randomized and allocated to one of the two interventions (antiseptic urinary catheters or conventional catheters). catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria. the main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. intention-to-treat analysis will be performed, as well as a primary analysis of all patients. the aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.

Eligibility criteria:
inclusion criteria: * male or female patients with traumatic or medical spinal cord injury * age of 18 years or above * patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days. * patients who are willing to participate in the study and give their written informed consent (if a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian). exclusion criteria: * patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector. * patients with urinary tract infection at the moment of inclusion * current antibiotic use or use within 7 days prior to inclusion * outpatients with sporadic medical examinations (less than one per month) * known allergy to latex, silver salts or hydrogels. * patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results. * pregnant or breastfeeding woman.

Keywords: spinal cord injuries urinary tract infection urinary catheters protocol randomized clinical trial
pilates method in people with ham/tsp

Conditions: HAM/TSP; HTLV-1 Secondary Myelopathy; Balance; Gait Balance; Functional Mobility

Summary: individuals with htlv-1 secondary myelopathy (ham/tsp) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. the aim of the study is to verify the therapeutic effect of a pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with ham / tsp. this is a randomized, crossover clinical trial performed with individuals with ham / tsp who are attended at a referral center who is able to perform gait whether or not to use a walking aid. amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. they will be allocated randomly to two groups. one will perform the pilates method protocol and the other task-oriented training. the first group, called test-control group (gtc), will initiate the protocol with exercises of the pilates method; the control-test group (gct) will initiate the task-oriented training protocol. a p \<0.05 will be considered a statistically significant difference.


Eligibility criteria:
inclusion criteria: * individuals with probable and/or defined diagnosis of ham / tsp, according to who criteria, of both sexes, aged 18 to 64 years. exclusion criteria: * individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.
clinical usefulness of mic/breakpoint ratio and penetration in tissues. a prospective study of clinical validation

Conditions: Infection of Skin and/or Subcutaneous Tissue

Summary: the general objective of the study is to assess whether the implementation of the antibiotic essay with the breakpoint/mic ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.


Eligibility criteria:
inclusion criteria: * written informed consent * bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections exclusion criteria: * age \< 18 years * inability to sign informed consent

Keywords: bacterial infection of skin or soft tissues
meropenem-fl058 phase 2 study in the treatment of complicated urinary tract infections

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

Summary: phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cuti), including acute pyelonephritis.treatment duration for each cohort was 7 to 14 days. patients were not permitted to switch to oral therapy.


Eligibility criteria:
inclusion criteria: 1. male or female patients, aged 18 \~ 75 years (inclusive);； 2. acute pyelonephritis or other complicated urinary tract infection. exclusion criteria: 1. patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups; 2. fungal urinary tract infection; 3. history of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors; 4. pregnant or breastfeeding women; 5. inability to tolerate intravenous fluids, due to medical reasons, of 1050 ml per day required for study drug administration; 6. unable or unwilling, in the judgment of the investigator, to comply with the protocol.
physiotherapist in the emergency department

Conditions: Emergencies; Fall

Summary: this study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate.


Eligibility criteria:
inclusion criteria: 1. patients aged 75 and over 2. patients admitted to emergency for falls. 3. clinically stable patient who may benefit from a gait assessment or fall risk assessment 4. patients able to understand the protocol and not verbally object to participation. exclusion criteria: 1. patients with limb fractures requiring surgical treatment 2. patients under guardianship or curatorship. 3. patients already included in an interventional research protocol.

Keywords: emergency department elderly person physiotherapist fall
study to learn more about safety of aflibercept injection in japanese patients with neovascular glaucoma (nvg)

Conditions: Neovascular Glaucoma

Summary: this is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of neovascular glaucoma. the investigator will have made the decision to use eylea for treatment. the objective of this study is to assess safety and effectiveness of eylea using in real clinical practice. patients will be followed for a time period of 6 months from start of eylea treatment or until it is no longer possible (e.g. lost to follow-up). in total, 480 patients will be recruited. for each patient, data are collected as defined in the electronic case report form (ecrf) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).


Eligibility criteria:
inclusion criteria: * diagnosis of nvg * patients who have received ivt-afl treatment according to japanese labeling. exclusion criteria: * patients who are contraindicated based on approved label * diagnosis of other indication
unilateral gpi vs unilateral stn dbs in the same patient with pd

Conditions: Parkinson Disease; Deep Brain Stimulation; Globus Pallidus Interna; Subthalamic Nucleus

Summary: the subthalamic nucleus (stn) and globus pallidus interna (gpi) are two main targets in the deep brain stimulation (dbs) treatment for parkinson's disease (pd). large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either gpi dbs or stn dbs, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of stn dbs in the medication reduction and the potential advantage of gpi dbs for cognitive, psychiatric and axial aspects. unfortunately, in such a highly heterogeneous disease of pd, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. moreover, most studies are investigating the difference between gpi and stn in different patients. in order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral stn stimulation versus unilateral gpi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral stn and contralateral gpi dbs. axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease * aged between 55 and 75 years, both male and female * patients who have undergone combined unilateral stn and contralateral gpi dbs for more than 6 months * a hoehn-yahr (h-y) stage of less than 4 in the off-medication state * a left-extremity to right-extremity ratio of less than 0.15 on the unified parkinson's disease rating scale part ⅲ (updrs-ⅲ) in the both off-medication and on-medication states exclusion criteria: * history of serious psychosis * history of intractable epilepsy (i.e., seizures) * diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions * dementia (a mini-mental state examination (mmse) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent * lack of cooperation * additional reasons for exclusion at the discretion of the clinical investigator * poorly controlled depression or anxiety * past history of suicidal attempt
does sevoflurane cause genomic damage

Conditions: Anesthesia; Adverse Effect

Summary: this study aims to find out if sevoflurane causes any cell damage to patients undergoing general anaesthesia. in case of any damage, the reversibility of the damage is also assessed. this is a prospective, comparative study carried out in all children scheduled for surgical repair of cleft lip or palate admitted in the department of plastic surgery under smile train organisation ìn our hospital,who satisfy the inclusion and exclusion criteria.

study goals and objectives 1. to find out if sevoflurane induces genomic instability in children undergoing cleft lip and palate repair. 2. to assess the magnitude of genomic damage caused by the sevoflurane anaesthesia. 3. to evaluate the reversibility of the induced genomic instability when exposure is discontinued. study design type of study : prospective comparative study research population : all children scheduled for surgical repair of cleft lip or palate admitted in the department of plastic surgery of our hospital, who satisfy the inclusion and exclusion criteria. sample size : a total of 30 children will be enrolled for the study. methodology children scheduled to undergo surgical repair of cleft lip or palate were enrolled for the study, after addressing the inclusion and exclusion criteria. a peripheral blood sample of 1.5 ml (s-1) will be taken before the induction of anaesthesia .all children will be randomly allocated into two groups - group s and p.all children will be premedicated with inj.glycopyrolate 0.01 mg/kg . children in group s will be induced with sevoflurane, whereas children in group p will be induced with propofol.all children will be intubated using i / v vecuronium 0.1 mg / kg .analgesia will be provided using i / v fentanyl 1.5 mcg / kg. depth of anaesthesia will be maintained with sevoflurane in group s and with propofol infusion in group p. the vitals will be monitored as usual intraop and the children will be extubated at the end of the surgery. peripheral blood samples of 1.5 ml each will be taken immediately after extubation (s-2) , after 48 hours (s-3)and after 120 hours (s-4).a fifth blood sample (s-5) will be taken on the 14th postoperative day all the blood samples will be evaluated for genomic instability using alkaline comet assay by the genetics lab of our hospital. statistical analysis the findings of this study will be analysed using chi-square test, student's t-test, mann-whitney u test, mean and standard deviation to yield the final results. the study will be considered statistically significant with a p value of less than 0.05

Eligibility criteria:
inclusion criteria * children must have isolated cleft lip or palate. * the surgery must be a primary repair of cleft lip or palate. * the minimum duration of the surgery must be 90 minutes. exclusion criteria * children who have undergone previous surgery. * children who have syndromic cleft lip or palate. * children with bleeding disorders. * children with known allergy to any of the concerned drugs.

Keywords: genomic instability sevoflurane general anaesthesia
autologous stem cell collection and reinfusion in newly diagnosed high grade gliomas

Conditions: Astrocytoma; Brainstem Glioma; Ependymoma; Mixed Glioma; Oligodendroglioma; Optic Nerve Glioma

Summary: the investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm\^3 four weeks after stem cell reinfusion in high grade glioma patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed newly diagnosed high grade glioma by pathology (who grade iii or iv). * at least 18 years of age. * karnofsky performance status ≥ 60% * normal bone marrow and organ function as defined below: * absolute neutrophil count ≥ 1,500/mcl * platelets ≥ 100,000/mcl * hematocrit ≥ 30% * absolute lymphocyte count ≥ 1000/mcl blood transfusions are permitted to allow potential participant to meet these criteria. * post-operative treatment plan must include standard radiation and temozolomide. * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, til, lak, or gene therapy), or hormonal therapy. glucocorticoid therapy is allowed. * anti-vegf therapy within 6 weeks of registration. * a history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * currently receiving any investigational agents that might affect lymphocytes. patients receiving novocure are allowed on study. * a history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study. * fresh cns bleed as evident by mri or ct. * contraindicated for anticoagulation. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test within 14 days of study entry. * known hiv-positivity.
impact of a telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases

Conditions: Inflammatory Rheumatism

Summary: paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases of the locomotion system. the annual rate incidence of children diagnosed with rheumatic disease in switzerland (canton of vaud) is 56.8 for 100'000 children. these children experience a chronic course of the disease impacting on their quality of life and family functioning. their medical treatment is significant and may last for life. caring for these children involves a multidisciplinary approach. control of the disease and management of the symptoms becomes of foremost importance to minimise disability and pain. in addition to medical care, the supporting role of nurses in the care of children with rheumatic diseases and their family aims to limit the potential for further deformity, disability, and psychological complications. in particular, they play a key role in supporting the specialist team caring for patients with rheumatism disease, recognising poor disease control and the need for changes in treatment, providing a resource to patients on treatment options and how to access additional support and advice, and identifying best practice to achieve optimal outcomes for the patients and their family. nurses also ensure the link between medical practitioner, other health providers, and family, thus play a key role in the follow-up care of the child and its family. follow-up of children and their family can be ensured by regular telephone consultation (telenursing) made by experienced nurse specialists in rheumatology. however, the effectiveness of telenursing remains to be proven in children with chronic rheumatic diseases. the aim of this study is, therefore, to evaluate the effect of a telephone nursing intervention on the outcomes of family and children with rheumatism chronic disease. this randomised crossover, experimental longitudinal study will be carried out in the outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of vaud. the population will consist of children newly diagnosed with inflammatory rheumatologic diseases and one of their parent. the nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and tn to ensure follow-up of the children and their family. the intervention will focus on providing affective support, health information, and aid to making decision.


Eligibility criteria:
inclusion criteria: * children under the age of 17 years at the time of enrolment into the study * newly diagnosed (within 24 months from the enrolment date) with inflammatory rheumatologic diseases * registered as outpatient in the clinic of paediatric rheumatology * a parent (the mother or the father or the guardian) on behalf of their children. exclusion criteria: * children and parents who do not understand and speak french * no access to a telephone line.

Keywords: telenursing children chronic illness nursing
the use of manuka honey to improve healing after third molars surgery

Conditions: Surgical Extraction of Impacted Third Molars

Summary: since there is an evidence that manuka honey is an antibacterial agent, the present study aims to confirm this characteristic and assess its effect in improving healing and reducing postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular third molars

sufficient evidence exists recommending the use of honey in the management of acute wounds and burns. studies revealed that the healing effect of honey could be classified by its antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components. manuka honey has been shown to inhibit a wide range of microorganisms, including multiresistant strains. this unique honey is derived from flowers of manuka tree (leptospermum scoparium) in new zealand. dihydroxyacetone and methylglyoxal are unique and naturally occurring constituents of manuka honey that correlate with its antibacterial activity. since surgical extraction of impacted molars is one of the most common operations in the oral cavity and the postoperative symptoms disturbing the patient may reduce the quality of health service, this study aims to assess the healing potential of manuka honey in reducing these symptoms by comparing the outcome of extraction of impacted lower molars with and without topical application of manuka honey into the extraction socket.

Eligibility criteria:
inclusion criteria: * asymptomatic, symmetrical, bilateral impacted third molars exclusion criteria: * uncontrolled diabetes, * hypersensitivity to honey * alcoholism, * drug abuse, * pathological condition in the region
effect of bifidobacterium on irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: there has been no data on effect of bifidobacterium breve on symptoms of patients with irritable bowel syndrome (ibs). we hypothesized that bifidobacterium breve is effective on symptoms of ibs patients.

there has been no data on effect of bifidobacterium breve on symptoms of patients with irritable bowel syndrome (ibs). we hypothesized that bifidobacterium breve is effective on symptoms of ibs patients. ibs patients will be enrolled via advertisement. any ibs subtypes will not be rejected. they will take either 1.0 g of bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. ibs symptoms and allied markers will be checked before, during, and after the administration.

Eligibility criteria:
inclusion criteria: * diagnosis of ibs with rome ii definition exclusion criteria: * diagnosis of serious diseases (both physically and mentally)

Keywords: stress brain-gut interactions visceral perception gastrointestinal motility emotion